510(k) K060277

BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM by Boehringer Laboratories — Product Code JCX

K060277 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 3, 2006. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2006
Date Received
February 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type